Detaljerad miljöinformation

Substance: sufentanil

Miljörisk: Risk för miljöpåverkan av sufentanil kan inte uteslutas då ekotoxikologiska data saknas.

Nedbrytning: Det kan inte uteslutas att sufentanil är persistent, då data saknas.

Bioackumulering: Sufentanil har låg potential att bioackumuleras. Detailed background information

Environmental Risk Classification

Predicted Environmental Concentration (PEC)

PEC is calculated according to the following formula:

PEC (μg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1.37*10-6*A(100-R)

PEC = 2.95*10-7 μg/L

Where:

A = 0.001675 kg (total sold amount API in Sweden year 2022, data from IQVIA).

R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)

P = number of inhabitants in Sweden = 10 *106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. I)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. I)

Predicted No Effect Concentration (PNEC)

No ecotoxicological study results are available, hence the PNEC (μg/L) could not be estimated.

Environmental risk classification (PEC/PNEC ratio)

The PEC/PNEC ratio could not be calculated due to lack of data and therefore justifies the phrase: "Risk of environmental impact of sufentanil cannot be excluded, since no ecotoxicity data are available".

However, according to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of sufentanil is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 μg/L.

Degradation

No degradation data are available, hence justifies the phrase: "The potential for persistence of sufentanil cannot be excluded, due to lack of data".

Bioaccumulation

Partitioning coefficient:

Log Pow = 3.45 (experimental by shake flask method) (Ref II)

Justification for bioaccumulation phrase:

Since log Log P < 4, the substance has low potential for bioaccumulation.

Excretion (metabolism)

Biotransformation of the substance occurs primarily in the liver and small intestine. Nearly 80% of the dose administered is eliminated within 24 hours, with only 2% in the form of the unchanged substance.

References

I. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

II. Roy, S.D., Flynn, G.L.: Solubility and related physicochemical properties of narcotic analgesics. Pharmaceutical Research 1988, Vol 5, No. 9, 580-586.

III. SmPC Sufentanil hameln 5 mikrogram/ml injektions-/infusionsvätska, lösning; Sufentanil hameln 50 mikrogram/ml injektions-/infusionsvätska, lösning. MA no. 62133 (5 mikrogram/ml); 62134 (50 mikrogram/ml) (2022-05-16).